Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01697631
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Inclusion Criteria
- Type 2 diabetes
- Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
- HbA1c (glycosylated haemoglobin) equal to or below 12%
- Willing and able to perform self blood glucose monitoring (SMBG)
Exclusion Criteria
- History of drug or alcohol dependence
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Previous participation in this trial
- Receipt of any investigational drug within the last month prior to this trial
- Known or suspected allergy to trial products or related products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin aspart biphasic insulin aspart 30 - BIAsp biphasic insulin aspart 30 - Insulin aspart insulin aspart -
- Primary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin)
- Secondary Outcome Measures
Name Time Method 7-point blood glucose profile Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification Incidence of adverse events Hypoglycaemic episodes (minor, major or nocturnal)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇵🇱Wroclaw, Poland